Clearance Summary
ULTRAFREE CALCIUM FILTER received FDA 510(k) clearance under submission number K801500, sponsored by Millipore Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1980-08-20.
- Submission: K801500
- Applicant / Sponsor: Millipore Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 1980-08-20
Classification & Regulation
This clearance is catalogued under FDA product code JRL and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.